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Compare Outcomes Between Two Acellular Dermal Matrices

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The Washington University

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Other: Cortiva 1mm Allograft Dermis
Procedure: Surgery
Procedure: Skin or nipple-sparing mastectomy
Other: Breast Q
Other: Alloderm RTU

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02891759
201608168

Details and patient eligibility

About

This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm Allograft Dermis (RTI Surgical®, Inc.). These are the thinnest versions of acellular dermal matrices (ADM) offered by both vendors and can be used for post-mastectomy breast reconstruction. Alloderm RTU medium has a thickness of 1.6±0.4 mm, while Cortiva 1mm Allograft Dermis has a thickness of 1.0±0.2 mm. In the context of breast reconstruction, these ADMs are used in the same manner. They may be inserted with a tissue expander immediately after skin- or nipple-sparing mastectomy. The investigators will examine breast-reconstruction associated complication rates, pre- and post-operative patient reported outcomes using the Breast Q, and physician reimbursement as well as direct hospital costs. The endpoint will be either exchange of the tissue expander for a permanent breast implant or autologous flap, explantation due to patient preference, development of a complication, or less common reasons. The investigators propose that Cortiva 1mm Allograft Dermis and Alloderm RTU will have equivalent complication and patient reported outcome rates as well as physician reimbursement, but that direct hospital cost will be less with Cortiva 1mm Allograft Dermis.

Enrollment

320 patients

Sex

Female

Ages

22 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Sex: Females
  • Age: 22 to 70 years old
  • Preoperative surgical plan: Immediate placement subpectoral (subpectoral and postpectoral are synonymous) tissue expander with ADM or Immediate placement prepectoral tissue expander or implant with ADM
  • Mastectomy type: Skin-sparing or nipple-sparing mastectomy with or without sentinel lymph node biopsy; may be unilateral or bilateral mastectomy
  • Able to understand and willing to sign IRB approved written informed consent document.

Exclusion criteria

-Pregnant and/or breastfeeding.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

320 participants in 2 patient groups

Group A: Alloderm RTU
Experimental group
Description:
* Prior to the date of mastectomy, the BREAST Q patient-reported outcome survey will be administered for routine clinical care purposes. It may occur before or after enrollment. * On the day of surgery, patients will receive standardized preoperative care, a skin- or nipple-sparing mastectomy from an experienced surgical breast oncologists and immediate tissue expander breast reconstruction with Dr. Myckatyn or Dr. Tenenbaum. Uniform operative techniques will be used in both treatment groups. All patients will receive either a 16x8 cm (128 sq cm) ADM graft for postpectoral reconstruction or 16x20 cm (320 sq cm) for prepectoral reconstruction. Patients randomized to Group A will receive Alloderm RTU * A post-operative version of the Breast Q validated in patients who have received tissue expanders will be administered between 1 and 3 months after tissue expander insertion, and again prior to exchange for an implant or flap (or at time of patient-requested removal
Treatment:
Other: Breast Q
Procedure: Skin or nipple-sparing mastectomy
Procedure: Surgery
Other: Alloderm RTU
Group B: Cortiva 1mm Allograft Dermis
Experimental group
Description:
* Prior to the date of mastectomy, the BREAST Q patient-reported outcome survey will be administered for routine clinical care purposes. It may occur before or after enrollment. * On the day of surgery, patients will receive standardized preoperative care, a skin- or nipple-sparing mastectomy from an experienced surgical breast oncologists and immediate tissue expander breast reconstruction with Dr. Myckatyn or Dr. Tenenbaum. Uniform operative techniques will be used in both treatment groups. All patients will receive either a 16x8 cm (128 sq cm) ADM graft for postpectoral reconstruction or 16x20 cm (320 sq cm) for prepectoral reconstruction. Patients randomized to Group B will receive Cortiva 1mm Allograft Dermis * A post-operative version of the Breast Q validated in patients who have received tissue expanders will be administered between 1 and 3 months after tissue expander insertion, and again prior to exchange for an implant or flap (or at time of patient-requested removal
Treatment:
Other: Breast Q
Procedure: Skin or nipple-sparing mastectomy
Procedure: Surgery
Other: Cortiva 1mm Allograft Dermis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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